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AFRICAT
Stepwise High Risk Individuals Screening for Atrial Fibrillation Using Sequential Clinical-electro-biological Register: the AFRICAT Study (Atrial Fibrillation Research In CATalonia)
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · FUNDACIO LA MARATO TV3
observational
492
1 country
2
Study Start
May 2016
Actual (reported)Primary Completion
April 2017
Actual (reported)Study Completion
October 2019
Actual (reported)The AFRICAT study is a prospective, multicenter, population-based study, which aims to create and apply a sequential screening program for atrial fibrillation (AF) in a high-risk population by integrating clinical, electrocardiographic and biological information. The study will be divided into three different phases of generation, validation and application of a screening program. In Phase I, from 8,000 individuals aged 65-75 with hypertension and diabetes identified from primary center registries, 100 will be randomly selected . In these patients, the investigators will complete clinical assessment, testing of different pulse-handheld ECG devices (MyDiagnostik, AliveCor and WatchBP) for AF screening, discovery of blood biomarkers for AF (by aptamer technology and RNA expression), and validation of biological candidates from the literature and previous results. All patients will receive Holter monitoring with a wearable device (NuuboTM). In parallel, a predictive risk model for AF will be developed from historical records from the areas in which the study will be carried out. This Phase I will be followed by a Phase II-validation phase of 400 patients, selected by the predictive model previously mentioned, belonging to the top risk quartile. In these patients, the best biomarkers and devices from phase I will be validated, and patients will be again monitored with the wearable Holter device. With the results from this validation analysis, a screening program (Phase III) based in the combination of clinical predictors, devices to detect AF (handheld-ECG or pulse wave detectors), blood biomarkers determination and long-term monitoring with wearable Holter. This program will be applied over the whole population targeted by the AFRICAT study, which corresponds to 8,000 patients from 65 to 75 years old, whit hypertension and diabetes mellitus as comorbidities.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2016
Actual (reported)April 2017
Actual (reported)June 13, 2017
Actual (reported)June 15, 2017
Actual (reported)October 2019
Actual (reported)Atrial fibrillation (AF) diagnosis
Absence of discrete P waves together with an irregular, arrhythmic pattern of ventricular activation, more than 30 seconds.
Study visit/1 month monitoring
All people included were managed by the Public Health System. Therefore 5,000 participants aged 65-75 with active diagnoses of hypertension (I10) and diabetes (E10.9 E11.9) will be selected from the electronic health record of Primary Care. Given that the registered prevalence of Atrial Fibrillation in this population is was 7.3%, the investigators estimated that around 2.8% will be newly diagnosed with AF at the first study visit. Therefore, the investigators estimate that the number of patients in this population who have undiagnosed AF might be from 140 to 210 patients, taking into account that AF detection should be improved in the study given the long-term monitoring.
SAP Terres de l'Ebre
Tortosa, Tarragona, 43500, Spain
SAP Muntanya
Barcelona, 08035, Spain
Abellana R, Gonzalez-Loyola F, Verdu-Rotellar JM, Bustamante A, Pala E, Clua-Espuny JL, Montaner J, Pedrote A, Del Val-Garcia JL, Ribas Segui D, Munoz MA. Predictive model for atrial fibrillation in hypertensive diabetic patients. Eur J Clin Invest. 2021 Dec;51(12):e13633. doi: 10.1111/eci.13633. Epub 2021 Jun 19.
Clua-Espuny JL, Muria-Subirats E, Ballesta-Ors J, Lorman-Carbo B, Clua-Queralt J, Pala E, Lechuga-Duran I, Gentille-Lorente D, Bustamante A, Munoz MA, Montaner J; AFRICAT Research Group. Risk of Atrial Fibrillation, Ischemic Stroke and Cognitive Impairment: Study of a Population Cohort >/=65 Years of Age. Vasc Health Risk Manag. 2020 Oct 28;16:445-454. doi: 10.2147/VHRM.S276477. eCollection 2020.
A blood sample of 32 cc divided into two serum tubes (8.5 cc), two plasma EDTA tubes (6 cc) and one TempusTM RNA tube (3 cc). Samples will be processed and stored at -20 ºC at the recruiting center until shipment to Neurovascular Research Laboratory, where the sample bank will be set up.
Joan Montaner Villalonga, PhD
Neurovascular Research Group
492 participants (actual enrollment reported by the registry).
First Submitted
June 13, 2017
First Posted
June 15, 2017
Study Start
May 2016
Actual (reported)Contact the study team to confirm eligibility.
Garcia-Berrocoso T, Pala E, Consegal M, Piccardi B, Negro A, Gill N, Penalba A, Huerga Encabo H, Fernandez-Cadenas I, Meisel A, Meisel C, Jickling GC, Munoz MA, Clua-Espuny JL, Pedrote A, Pagola J, Juega J, Bustamante A, Montaner J. Cardioembolic Ischemic Stroke Gene Expression Fingerprint in Blood: a Systematic Review and Verification Analysis. Transl Stroke Res. 2020 Jun;11(3):326-336. doi: 10.1007/s12975-019-00730-x. Epub 2019 Sep 2.
Muria-Subirats E, Clua-Espuny JL, Ballesta-Ors J, Lorman-Carbo B, Lechuga-Duran I, Fernandez-Saez J, Pla-Farnos R, On Behalf Members Of Africat Group. Incidence and Risk Assessment for Atrial Fibrillation at 5 Years: Hypertensive Diabetic Retrospective Cohort. Int J Environ Res Public Health. 2020 May 16;17(10):3491. doi: 10.3390/ijerph17103491.
Pala E, Bustamante A, Clua-Espuny JL, Acosta J, Gonzalez-Loyola F, Ballesta-Ors J, Gill N, Caballero A, Pagola J, Pedrote A, Munoz MA, Montaner J. N-Terminal Pro B-Type Natriuretic Peptide's Usefulness for Paroxysmal Atrial Fibrillation Detection Among Populations Carrying Cardiovascular Risk Factors. Front Neurol. 2019 Nov 29;10:1226. doi: 10.3389/fneur.2019.01226. eCollection 2019.
Primary Completion
April 2017
Actual (reported)Study Completion
October 2019
Actual (reported)Last Updated
April 11, 2022
Record last verified: 2022-04
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